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Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial


N/A
20 Years
80 Years
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial


This prospective study was designed to compare the quality of life after sphincter saving
surgery and abdominoperineal resection. Because of ethical issues, it is difficult to
conduct as a randomized trial. On the basis of tumor location, extent, and preoperative anal
function, patient will be attributed to two different operative method groups. Sample sized
was calculated as 294 patients in the estimated enrollment of 1 to 3(APR: ISR)


Inclusion Criteria:



- Low rectal cancer (5cm from anal verge by surgeon's digital rectal exam / rigid
rectoscopy)

- Patient who understands and accepts to sign the informed consent form

- Confirmed preoperative colonoscopic biopsy (adenocarcinoma)

- Proper bone marrow function

- Proper renal function

- Proper liver function

- No severe comorbidity

Exclusion Criteria:

- Metastatic lesion detected in preoperative assessment

- Previous history of cancer disease. (except patients with skin cancer)

- Severe heart disease, congestive heart disease.

- Severe lung disease, respiratory failure.

- Mental illness.

- Invasion to prostate, bladder and combined resection needed (partial or radical.•
Legally prohibited for clinical trial.

- Pregnancy or breast feeding.

- Previous disease or disability expected to influence the assessment of postoperative
quality of life.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality of life

Outcome Description:

Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Sung-Bum Kang, Ph. D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Bundang Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

APR-SPS trial

NCT ID:

NCT01461525

Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

  • Rectal Cancer
  • Low Rectal Cancer
  • Sphincter preservation
  • Abdominoperineal resection
  • Quality of life
  • Sexual function
  • Urinary function
  • Oncologic outcome
  • Rectal Neoplasms

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